Ignite Creation Date:
2024-05-06 @ 11:18 AM
Last Modification Date:
2024-10-26 @ 12:43 PM
Study NCT ID:
NCT03480399
Status:
UNKNOWN
Last Update Posted:
2019-08-07
First Post:
2016-09-07
Brief Title:
Long Term Morbidity and Quality of Life in Retroperitoneal Sarcomas
Sponsor:
Fondazione IRCCS Istituto Nazionale dei Tumori Milano
Organization:
Fondazione IRCCS Istituto Nazionale dei Tumori Milano
Study Overview
Official Title:
Long Term Morbidity and Quality of Life After Multivisceral Resection for Primary Retroperitoneal Soft Tissue Sarcomas a Prospective Observational Study
Status:
UNKNOWN
Status Verified Date:
2019-08
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LTM
Brief Summary:
No prospective data exist about long term morbidity and quality of life after multivisceral surgical resection for retroperitoneal soft tissue sarcoma RSTS
In order to assess the safety of this surgical approach and the effect on the Quality of Life over the long period we propose a prospective observational study
The hypothesis is that the surgical treatment has no significant impact in determining a lower Quality of Life in the long term
Objectives Primary objective Estimate the difference between baseline and 4 and 12 months scores of the global health status QoL scale in patients primarily treated for localized RSTS as determined in QLQ-C30 version 30
Secondary objectives
Evaluate the long term morbidity of aggressive surgical approach to RSTS in terms of renal failure
Evaluate the difference between baseline and 4 and 12 months scores of DN4 LEFS BPI questionnaires
Evaluate the difference between baseline and 4 and 12 months scores of the following scales from QLC-C30 PF2 RF2 EF CF SF FA FI
Evaluate the difference between baseline and 4 and 12 months scores of the following scales and single items from QLC-C29 Blood and mucus in stool Stool frequency Sexual interest Impotence Dyspareunia
To correlate the surgical resection pattern number and type of organs resected and the tumor features size grading and histological subtype with the long-term morbidity and quality of life
Eligibility Inclusion criteria
Adult patients age 18 years with primary localized RSTS surgically treated at our institution
Written voluntary informed consent
Exclusion criteria
- Recurrent disease
In order to assess the safety of this surgical approach and the effect on the Quality of Life over the long period we propose a prospective observational study
The hypothesis is that the surgical treatment has no significant impact in determining a lower Quality of Life in the long term
Objectives Primary objective Estimate the difference between baseline and 4 and 12 months scores of the global health status QoL scale in patients primarily treated for localized RSTS as determined in QLQ-C30 version 30
Secondary objectives
Evaluate the long term morbidity of aggressive surgical approach to RSTS in terms of renal failure
Evaluate the difference between baseline and 4 and 12 months scores of DN4 LEFS BPI questionnaires
Evaluate the difference between baseline and 4 and 12 months scores of the following scales from QLC-C30 PF2 RF2 EF CF SF FA FI
Evaluate the difference between baseline and 4 and 12 months scores of the following scales and single items from QLC-C29 Blood and mucus in stool Stool frequency Sexual interest Impotence Dyspareunia
To correlate the surgical resection pattern number and type of organs resected and the tumor features size grading and histological subtype with the long-term morbidity and quality of life
Eligibility Inclusion criteria
Adult patients age 18 years with primary localized RSTS surgically treated at our institution
Written voluntary informed consent
Exclusion criteria
- Recurrent disease
Detailed Description:
Study description This is an observational study aimed to prospectively evaluate the long term morbidity of aggressive surgical approach to RSTS and the impact over the patients quality of life Consecutive patients candidate to surgery for primary RSTS will be offered to be enrolled We plan to include all the RSTS patients consecutively operated on for primary retroperitoneal sarcoma from first accrual on up to the 24 months after the study start
At the entrance of the study an informed written consent will be obtained Study participants will be asked to complete four self-filled in one-off questionnaires see Study parameters paragraph
Study parameters Study parameters EORTC QLQ-CR29 and EORTC QLQ C30 questionnaires baseline 4 mos 12 mos LEFS questionnaire baseline 4 mos 12 mos BPI questionnaire baseline 4 mos 12 mos DN4 questionnaire baseline 4 mos 12 mos Serum creatinin baseline 4 mos 12 mos Morbidity events 4 mos 12 mos Neurologic exam of lower limbs baseline 4 mos 12 mos Disease status 4 mos 12 mos
In case of preoperatory complementary treatment the questionnaires will be administrated just before the beginning of the treatment
Quality of Life the core questionnaire the EORTC QLQC30is an extensively validated questionnaire for the assessment of health related quality of life in cancer patients Aaronson 1991 It contains both functional physical role cognitive emotional social and physical symptom multidimensional scales fatigue pain and nausea and vomiting as well as two single item global health status and quality of life scales plus several single-item symptom measures The QLQ-CR29 is a condition specific module colo-rectal disease developed to be used in conjunction with EORTC QLQC30 it is made up of 29 items for a total of four scales assessing urinary frequency faecal seepage stool consistency and body image as well a number single items scales Both the tools are available and validated in the Italian language
Femoral Impairment the dedicated questionnaire Lower Extremity Functional Scale - Italian Version LEFS questionnaire will investigated daily life activities that require ad adequate function of knee joint stability and quadriceps strength as a surrogate of motor impairment of homolateral femoral nerve
Chronic Pain Syndrome the Italian version of the Brief Pain Inventory Short form BPI attached will be administered in order to obtain information on pain status at censored time basal 4 and 12 months after surgery values
Neuropathic Pain the Italian version of Douleur Neuropathique en 4 Questions DN4 attached will be administered in order to obtain information on neuropathic pain at censored time basal 4 and 12 months after surgery scores
Long term morbidity morbidity events will specifically regard femoral nerve impairment at physical examination abdominal complications sexual life and physiological functions Renal failure in particular will be investigated by renal function blood tests monitoring and glomerular filtration rate GFR calculated according to Cockroft-Gault and simplified MDRD Modification of Diet in Renal Disease methods Serum creatinine value will also be registered Renal failure will be defined according to National Kidney Foundation 2002 criteria Stage 2 or higher and classified according to GFR thresholds
Disease status will be recorded and in case of local andor distant relapse the date of events will also be retrieved
Statistical considerations Statistical analyses
1 Primary end-point The two-sided 95 confidence interval 95CI of the paired difference between baseline and 4 or12 months scores will be calculated for the primary outcome scale variables items 29 and 30 QLQ-C30
2 Secondary end-points Descriptive statistics and frequency tabulation were used to summarize patient characteristics and long term morbidity profile Continuous variables will be described with appropriate summary statistics such as the mean median standard deviation minimum and maximum Categorical variables will be tabulated with frequencies and percentages The probabilities of renal failure and femoral neuropathy will be estimated by the corresponding relative frequencies their corresponding 95 confidence limits will be calculated using the exact method ie taking into account the binomial distribution of proportions The binary associations between the surgical resection pattern number and type of organs resected and the tumor features size grading and histological subtype will be tested by using exact chi-square test As regards the quantitative parameters measured over time summary statistics mean median standard deviation minimum and maximum or frequencies and percentages - as appropriate for the type of data - will be summarized by each time point mixed models will be used to analyze the longitudinal measurements allowing to take into account the within subject correlation and to straightforwardly analyze unbalanced data that may arise in the study
Interim Analysis We plan to performed an interim cross-sectional analysis at the end of patient enrollment in order to describe the study population at baseline according to the primary and secondary endpoints
Sample size
We plan to include all the RSTS patients consecutively operated on for primary retroperitoneal sarcoma from first accrual on for the next 24 months about 60 patients estimated
A sample size of 60 patients allows the estimation of a two-sided 950 confidence interval for the paired difference between baseline and post treatment scores with a precision half CI width of 025 times the standard deviation of the difference
At the entrance of the study an informed written consent will be obtained Study participants will be asked to complete four self-filled in one-off questionnaires see Study parameters paragraph
Study parameters Study parameters EORTC QLQ-CR29 and EORTC QLQ C30 questionnaires baseline 4 mos 12 mos LEFS questionnaire baseline 4 mos 12 mos BPI questionnaire baseline 4 mos 12 mos DN4 questionnaire baseline 4 mos 12 mos Serum creatinin baseline 4 mos 12 mos Morbidity events 4 mos 12 mos Neurologic exam of lower limbs baseline 4 mos 12 mos Disease status 4 mos 12 mos
In case of preoperatory complementary treatment the questionnaires will be administrated just before the beginning of the treatment
Quality of Life the core questionnaire the EORTC QLQC30is an extensively validated questionnaire for the assessment of health related quality of life in cancer patients Aaronson 1991 It contains both functional physical role cognitive emotional social and physical symptom multidimensional scales fatigue pain and nausea and vomiting as well as two single item global health status and quality of life scales plus several single-item symptom measures The QLQ-CR29 is a condition specific module colo-rectal disease developed to be used in conjunction with EORTC QLQC30 it is made up of 29 items for a total of four scales assessing urinary frequency faecal seepage stool consistency and body image as well a number single items scales Both the tools are available and validated in the Italian language
Femoral Impairment the dedicated questionnaire Lower Extremity Functional Scale - Italian Version LEFS questionnaire will investigated daily life activities that require ad adequate function of knee joint stability and quadriceps strength as a surrogate of motor impairment of homolateral femoral nerve
Chronic Pain Syndrome the Italian version of the Brief Pain Inventory Short form BPI attached will be administered in order to obtain information on pain status at censored time basal 4 and 12 months after surgery values
Neuropathic Pain the Italian version of Douleur Neuropathique en 4 Questions DN4 attached will be administered in order to obtain information on neuropathic pain at censored time basal 4 and 12 months after surgery scores
Long term morbidity morbidity events will specifically regard femoral nerve impairment at physical examination abdominal complications sexual life and physiological functions Renal failure in particular will be investigated by renal function blood tests monitoring and glomerular filtration rate GFR calculated according to Cockroft-Gault and simplified MDRD Modification of Diet in Renal Disease methods Serum creatinine value will also be registered Renal failure will be defined according to National Kidney Foundation 2002 criteria Stage 2 or higher and classified according to GFR thresholds
Disease status will be recorded and in case of local andor distant relapse the date of events will also be retrieved
Statistical considerations Statistical analyses
1 Primary end-point The two-sided 95 confidence interval 95CI of the paired difference between baseline and 4 or12 months scores will be calculated for the primary outcome scale variables items 29 and 30 QLQ-C30
2 Secondary end-points Descriptive statistics and frequency tabulation were used to summarize patient characteristics and long term morbidity profile Continuous variables will be described with appropriate summary statistics such as the mean median standard deviation minimum and maximum Categorical variables will be tabulated with frequencies and percentages The probabilities of renal failure and femoral neuropathy will be estimated by the corresponding relative frequencies their corresponding 95 confidence limits will be calculated using the exact method ie taking into account the binomial distribution of proportions The binary associations between the surgical resection pattern number and type of organs resected and the tumor features size grading and histological subtype will be tested by using exact chi-square test As regards the quantitative parameters measured over time summary statistics mean median standard deviation minimum and maximum or frequencies and percentages - as appropriate for the type of data - will be summarized by each time point mixed models will be used to analyze the longitudinal measurements allowing to take into account the within subject correlation and to straightforwardly analyze unbalanced data that may arise in the study
Interim Analysis We plan to performed an interim cross-sectional analysis at the end of patient enrollment in order to describe the study population at baseline according to the primary and secondary endpoints
Sample size
We plan to include all the RSTS patients consecutively operated on for primary retroperitoneal sarcoma from first accrual on for the next 24 months about 60 patients estimated
A sample size of 60 patients allows the estimation of a two-sided 950 confidence interval for the paired difference between baseline and post treatment scores with a precision half CI width of 025 times the standard deviation of the difference
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None